Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment

December 3, 2024 updated by: He Eye Hospital
To determine whether provision of free spectacles to rural-dwelling Chinese secondary school students with visually-significant refractive error, together with a teacher-based incentive to promote their use, increases the proportion of children going on to academic high school, as opposed to dropping out or pursuing a vocational track.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators propose in the current trial to significantly expand the evidence base for spectacle distribution as the most-effective health intervention to improve educational opportunities for China's under-served rural children and adolescents by assessing impact on school attainment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1980

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Year 1 students (about 12-15 years old) from schools in county-level cities and below in Liaoning Province
  • Uncorrected (self-glasses) visual acuity of ≤6/12 in both eyes
  • Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected7 (myopia ≤-0.75 diopters (D, or astigmatism (non-spherical refractive error) ≥1.00 D
  • Best corrected visual acuity ≥6/7.5 in either eye

Exclusion Criteria:

  • Hyperopia ≥2.00 D
  • Presence of visually-significant ocular condition besides refractive error

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
Children at Intervention schools will receive free spectacles of a design they select, based on the child's measured refractive power and dispensed at school by the teacher. All students will be advised to wear glasses as much as possible during the study to ensure clear vision.
Device: free spectacles
Children will receive free spectacles
No Intervention: Control group
Children at Control schools will receive a glasses prescription and letter to the parents informing them of the refractive status of their child, with free glasses provided only at the end of the trial. Service offered to the Control group exceeds standard care, in that no school-based programs of vision screening and refraction currently exist in the study area, or in most of rural China.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance at academic high school
Time Frame: In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.
This will be assessed by systematically contacting parents, teachers and students to ascertain enrolment status, which REAP has used to obtain > 97% follow-up in previous studies of high school accession. In the event of inconsistent responses, priority will be given to responses of parents, then teachers and finally students
In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression and Anxiety
Time Frame: At baseline and 12 months post-treatment
Depression and anxiety score measured with Anxiety Stress Scale (DASS). The score range for depression, anxiety and stress are 0-42, with higher score indicates more severe mental health problems.
At baseline and 12 months post-treatment
Self Esteem
Time Frame: At baseline and 12 months post-treatment
Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem.
At baseline and 12 months post-treatment
Progression of Shortsightedness
Time Frame: At baseline and 12 months post-treatment
Progression of Shortsightedness will be measured using change in refraction over time
At baseline and 12 months post-treatment
Compliance with spectacle wear
Time Frame: After 12 months of participant followup
Actual presence of spectacles on the child's face (rather than having glasses at school)at the time of an unannounced examination.
After 12 months of participant followup
Classroom use of blackboards versus textbooks
Time Frame: After 12 months of participant followup
Frequency of blackboard versus textbook use in the major subjects (Maths Chinese, English) on a questionnaire administered to teachers, and answered as "all", "most", "about half", little" or "none" of teaching.
After 12 months of participant followup
Cost effectiveness of intervention.
Time Frame: At study closeout, after 32 months of participant follow up
Calculated as ratio of incremental cost to proportion of children who continue to academic high school as opposed to vocational high school or no schooling. Incremental cost is the difference of costs between implementation of intervention and control, Intervention costs will comprise the screening test glasses (including replacements).
At study closeout, after 32 months of participant follow up
Emotional and behavioral problems
Time Frame: At baseline and 12 months post-treatment
Emotional and behavioral problems score using the Strengths and Difficulties Questionnaire (SDQ), with difficulties score ranges from 0 to 40, Prosocial scale ranges from 0-10,with higher score indicates severe mental health and behavioral problems.
At baseline and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
He Eye Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Guanghao Qin, He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWISH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized datasets generated and analyzed during the current study will be made available on reasonable request by the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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